The new regulation on medical products, the Medical Device Regulation (MDR) 2017/745 (MDR), which replaces previous guidelines Medical Device Directive (MDD) 93/42/EEC and Active Implantable Medical Devices (AIMD) 90/385/EEC, has entered into force as from 2017. All manufacturers of Class I to III medical products must familiarize themselves with the new requirements as soon as possible. The regulation has far-reaching implications and affects all classes of medical products. For the first time, products that are not medical products as such are regulated by the Medical Device Regulation (MDR). Among the aspects changed are the classification of products, previous basic requirements, technical documentation, clinical evidence, market surveillance, and quality management systems. The European approval process is uniformly regulated and entails significant changes in terms of organization goals. The new scrutiny procedure, reprocessing requirements, and the introduction of the European database Eudamed also bring about profound changes. In our one-day seminar, you will gain a compact overview to align your company with the new requirements of the Medical Device Regulation (MDR).
- Contents and Fundamentals of the Medical Device Regulation (MDR)
- Classification/Reclassification of Products
- Non-Medical Products within the Scope of the Medical Device Regulation (MDR)
- Common Technical Specifications
- New Basic Requirements
- Content Requirements for Technical Documentation
- Post Market Surveillance
- Scrutiny Procedure
- Validity of Conformity Assessment and Certification, Transition Periods
- Requirements for Different Actors, E.g.:
- EU Representatives
- Distributors and Service Partners
- Role of Contact Person for Regulatory Compliance
- Eudamed Database
- UDI (Unique Device Identification)
Who should attend
- Newcomers in the medical device industry
- Expert and executive personnel to update their knowledge
- Personnel in charge of regulatory affairs
- Personnel in quality management
- Consultants in the medical device industry
certificate of attendance TÜV SÜD Akademie
The hand-out is english. A pocketbook Medical Device Regulation (MDR) is included in the seminar price.
TÜV SÜD Akademie senior expert trainers
- The new legal requirements of the Medical Device Regulation (MDR) will be provided to you in a compact form.
- You will receive an overview of the efficient and safe manufacture of medical products in accordance with the Medical Device Regulation (MDR).
- You will gain an understanding of your responsibilities and obligations as a manufacturer, EU representatives, importers and distributers of medical devices Class I to III.